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National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097513
First Posted: November 25, 2004
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Genentech, Inc.
  Purpose
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.

Condition Phase
Dwarfism, Pituitary Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Study Start Date: February 2003
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pubertal Growth Hormone Deficiency
Criteria

Inclusion Criteria:

  • Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
  • Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
  • Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
  • Ability to keep follow-up appointments throughout the study
  • Willingness to remain on therapy until epiphyseal closure is achieved
  • Prior enrollment in NCGS Core Study 85-036

Exclusion Criteria:

  • Treatment with non-Genentech GH preparation
  • Closed epiphyses
  • Active neoplasia
  • Treatment with insulin for diabetes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097513


Locations
United States, California
Genentech Central Contact
South San Francisco, California, United States, 94080
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Barbara Lippe, M.D. Genentech, Inc.
  More Information

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097513     History of Changes
Other Study ID Numbers: 85-036, Substudy 12
First Submitted: November 24, 2004
First Posted: November 25, 2004
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by Genentech, Inc.:
Pubertal Growth Hormone Deficiency

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs